PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)
| ISRCTN | ISRCTN14367816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14367816 |
| Secondary identifying numbers | E528/26 |
- Submission date
- 03/01/2001
- Registration date
- 03/01/2001
- Last edited
- 06/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Diana Gibb
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| Phone | +44 (0)20 7670 4709 |
|---|---|
| d.gibb@ctu.mrc.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | PERA |
| Study objectives | To evaluate whether the use of resistance testing using a centralised genotypic assay with computer assisted interpretation (VIRCO 'virtual phenotype') to make decisions about a new regimen results in a greater reduction in human immunodeficiency virus (HIV)-1 RNA in HIV infected children than choice based on drug history and clinical factors alone |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Paediatric HIV |
| Intervention | Children randomised to Arm 1 will have access to a centralised genotypic assay, with computer assisted interpretation based on a database of linked results from genotypic and phenotypic testing. Children randomised to Arm 2 will receive no resistance testing. |
| Intervention type | Other |
| Primary outcome measure | The primary end-point is plasma HIV-1 RNA at 12 months measured in the central laboratory using the Roche ultra-sensitive assay (limit of detection 50 copies/ml) |
| Secondary outcome measures | 1. Plasma HIV-1 RNA at 24 weeks 2. CD4 count adjusted for age at 12 months, measured locally 3. Antiretroviral therapy (ART) prescribed, in particular the number of switches in ART and drugs used 4. Adherence to ART prescribed (as measured by questionnaire) 5. Available drug options at 12 months 6. Progression to new acquired immunodeficiency syndrome (AIDS) defining event or death 7. Tolerability of, and adverse events to ART in the two arms 8. Proportion of children with viral load <50 copies/ml at 12 months |
| Overall study start date | 01/06/2000 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180, 170 recruited as of Sept 2006 |
| Key inclusion criteria | 1. Confirmed HIV-infected 2. Age 3 months to 18 years 3. Currently receiving and stable on the same antiretroviral therapy for at least 1 month; OR, if not on therapy, stopped within the last 2 weeks 4. Parents/guardians, and children where appropriate, are willing and able to give informed consent 5. Previous exposure to two or three classes of antiretroviral drugs, or, if exposed to nucleoside analogue reverse transcriptase inhibitors (NRTI) only, either exposed to three NRTI or two NRTI for more than 2 years 6. The paediatrician is likely to change treatment 7. Most recent HIV RNA result was >2000 copies/ml 8. Paediatrician and parents are willing to wait 3 weeks for the resistance assay result before switching therapy 9. Local resistance testing will not be done during the trial |
| Key exclusion criteria | 1. A previous resistance test, assessing both reverse transcriptase and protease inhibitor drug resistance has been performed while the child is on the current regimen. Children who have had a test on a previous regimen may be enrolled to a maximum recruitment of 30 children. 2. Unlikely to comply with the routine schedule of visits |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- Brazil
- England
- Germany
- Italy
- Portugal
- Spain
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2006 | Yes | No |
